Below is a list of processes and procedures EMS providers should have in place, and filed in their document control department, to help manage quality integrity of provider service offerings for OEM product programs.
This list is not comprehensive but can be used as a guideline.
The list is arranged by upper-level quality subject or function, followed by subsequent or corresponding related processes or procedures for that subject or function.
For EMS providers, this list can be used to determine if any quality-related processes or procedures are missing to help build OEM confidence in provider capabilities.
For OEMs, this list can help you gain a greater depth of understanding during your provider evaluation process in terms of an EMS provider’s scope of understanding quality, and relevant processes and procedures the provider has in place (or needing to be implemented), to meet minimum industry standards.
This list was compiled over several years working with both OEM and EMS companies. QRA stands for quantitative or qualified risk assessment. (See, also: Driving a quality focus in manufacturing teams)
TABLE OF CONTENTS
Quality processes and procedures for EMS providers
Documentation Control
A. Document Numbering, Handling, and Storage Process
B. Control of Customer Provided Documentation
- Specification and Source Control Drawings
C. Configuration Control Board Process
- Documentation Revision Control Procedure
- Documentation Deviation and Waiver Process
Quality and Reliability Assurance
A. Quality Policy and Mission Statement
- Quality and Reliability Assurance Organization
B. Customer Documentation Review Procedure
- Quantitative or qualified risk assessment (QRA) Proposal Support Process
- QRA / Program Management Coordination Policy
- QRA / Production Team Coordination Policy
C. Quality Audits / Production Control
- Selection of Internal Auditor Procedure
- PCBA and Box Out-of-Box Audit Procedure
- Process Audit Procedure
- Customers’ Audit Procedure
- In-Process Production Team Audit Procedure
- Preventative Action and Review Procedure
- Internal Audit Procedure
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Material Review Board
A. Non-Conforming Material Procedure
- Disposition and Control of Return to Vendor Material
- Disposition of Scrap Material Procedure
Material Control
A. Supplier Approval Procedure
- Approved Manufacturers’ List (AML)
- Approved Vendors List (AVL) Procedure
B. Purchased Material Quality Assurance Procedure
- Customer-Furnished Material Quality Assurance Procedure
- Review and Approval of Production Bill-of-Materials
C. In-coming Receiving Quality Assurance Procedure
D. Production Kit Development, Handling, and Audit Procedure
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